Software license key regulatory requirements

Hi,

Does anyone have experience in making a license key available for the customer to access additional functionality of a medical device software (product has a hw - not SaMD), including how it is made available to the customer (license? product code? etc), installation and requirements regulatory (CE, FDA, Anvisa)?
I understand that regulatory approval must be performed considering the complete software, but how to relate regulatory approval (which may be requested by the customer) of the complete software, mentioned in the technical documentation, with the license code or with the code of the "product" sold (additional functionality)?

Thank you in advance!

My initial thought is manage it as 2 variants of the same device - a basic variant and an enhanced one. Bundle both in the same regulatory submission and clearance - you will have 2 sub-models cleared. I feel that from a regulatory perspective it matters less whether the upgrade is HW or SW and how you implement it; in essence it's a given device, that upon certain actions can be transformed into another. Both are cleared so there shouldn't be a regulatory problem.

I would also look out for risks that additional functionality can be "unlocked" without the key provided, and how it affects device usage, patient safety etc.

Hey there,
We have the same question in our compagny. We design and develop SaMD but we need to do some configuration for our pharma customers. They use our soft in their clinical studies. How could we handle that? You said, Ronen E, that we could bundle the variants in the same regulatory submission, how is that please? Especially that we obtain the CE marking first and the configurations come after. Thanks a lot.

For FDA-regulated devices, the submission should include software information in accordance with the FDA guidance for the content of Premarket Submissions for Software Contained in Medical Devices. This information should include a description of the software requirements, device performance requirements, potential system hazards, and the software and/or hardware functions implemented as a result of such potential hazards.

See:
Policy for Device Software Functions and Mobile Medical Applications
https://www.fda.gov/files/medical d...ces---Guidance-for-Industry-and-FDA-Staff.pdf

Once the software has been approved, the manufacturer should provide the customer with the necessary license code or product code to access the approved software version and its functionalities. This information should be made available to the customer through documentation, such as user manuals or instructions for use, or through electronic means, such as software downloads or online portals.

Fadila19821982 said:

Hey there,
We have the same question in our compagny. We design and develop SaMD but we need to do some configuration for our pharma customers. They use our soft in their clinical studies. How could we handle that? You said, Ronen E, that we could bundle the variants in the same regulatory submission, how is that please? Especially that we obtain the CE marking first and the configurations come after. Thanks a lot.

Click to expand...

Hi,

My comments related to a situation where the variants already exist (ready for regulatory clearance) at the time of submission.

If you intend to add variants/functionality to a CE clearance after the case, you will need to consult with your NB (for devices > Class 1) or redo your internal process (Class 1).

Cheers,
Ronen

Hi,
Thanks for the clarifications.
My best
Fadila

Orca1 said:

For FDA-regulated devices, the submission should include software information in accordance with the FDA guidance for the content of Premarket Submissions for Software Contained in Medical Devices. This information should include a description of the software requirements, device performance requirements, potential system hazards, and the software and/or hardware functions implemented as a result of such potential hazards.

See:

Once the software has been approved, the manufacturer should provide the customer with the necessary license code or product code to access the approved software version and its functionalities. This information should be made available to the customer through documentation, such as user manuals or instructions for use, or through electronic means, such as software downloads or online portals.

Click to expand...

Dear Orca,
You said "the manufacturer should provide the customer with the necessary license code or product code to access the approved software version and its functionalities ". howa can we built those licence or product codes?
Thanks
Fadila

Fadila19821982 said:

Dear Orca,
You said "the manufacturer should provide the customer with the necessary license code or product code to access the approved software version and its functionalities ". Is there a requirement for that?
Thanks
Fadila

Click to expand...

Not that I am aware of. The portion about license keys was written in reference to vrgoncalves' question about functionally delivering it to the customer.

Orca1 said:

Not that I am aware of. The portion about license keys was written in reference to vrgoncalves' question about functionally delivering it to the customer.

Click to expand...

Thanks Orca.